Vaginal Microbiome and IVF Pregnancy Outcome

Description

The aim of this prospective, observational study is to investigate the prevalence of vaginal dysbiosis among women undergoing IVF procedures in the US. And to investigate the associations between the vaginal microbiome and the pregnancy outcome following IVF.

Conditions

Vaginal Flora Imbalance

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Study Overview

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Study Details

Study overview

The aim of this prospective, observational study is to investigate the prevalence of vaginal dysbiosis among women undergoing IVF procedures in the US. And to investigate the associations between the vaginal microbiome and the pregnancy outcome following IVF.

Associations Between the Vaginal Microbiome, Inflammatory Status and Pregnancy Outcome - a Prospective, Observational Study in Women Undergoing Frozen Embryo Transfers.

Vaginal Microbiome and IVF Pregnancy Outcome

Condition
Vaginal Flora Imbalance
Intervention / Treatment

-

Contacts and Locations

Waltham

Boston IVF The Waltham Center, Waltham, Massachusetts, United States, 02451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-44 years
  • * Patients whose written informed consent approved by the Institutional Review Board (IRB) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
  • * Women undergoing a planned frozen embryo transfer
  • * BMI between 18.5-35 kg/m2 (both included)
  • * Must be able to understand and read the informed consent form in English.
  • * Current diagnosis of pathologies or malformations that affect the uterine cavity such as polyps, intramural myoma, adhesions, fibroids or hydrosalpinx.
  • * Any illness or medical condition that is unstable or which, according to medical criteria and Investigator's discretion may put at risk the patient's safety and her compliance in the study.
  • * Participants currently taking antibiotics or with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to need antibiotic treatment during the observational period of this study.
  • * Systemic and/or vaginally applied antibiotic use within the last month prior to screening (except for prophylactic antibiotics related to egg retrieval).
  • * Patients utilizing oral contraceptive pills in the past month
  • * Latex or silicone allergy (Diva Cup and Vaginal Disc)

Ages Eligible for Study

18 Years to 44 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Freya Biosciences ApS,

Denis Vaughan, PhD, PRINCIPAL_INVESTIGATOR, Boston IVF

Denny Sakkas, PhD, PRINCIPAL_INVESTIGATOR, Boston IVF

Study Record Dates

2024-01-15